Bard Medical Recalls Arctic Sun Temperature Management Systems Due to Wiring Defect
Bard Medical Division is recalling 5,608 Arctic Sun 5000 Temperature Management Systems because an improper wiring connection may cause overheating and component failure.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a risk of overheating and component failure, which poses a risk of harm to patients, but no specific injuries or illnesses have been reported in the source text.
Plain-English summary
Bard Medical Division is recalling 5,608 units of the Arctic Sun Temperature Management System, Model 5000. This non-invasive thermal regulating system is indicated for monitoring and controlling patient temperature in adult and pediatric patients of all ages.
The recall is due to an improper wiring connection on the chiller assembly. This defect may result in overheating of the connection and potential failure of certain components in the system. The recall covers product codes 5000-00-00, 5000-00-00L, 5000-00-00E, 5000-01-01, 5000-01-01L, 5000-01-02, 5000-01-03, 5000-01-04, 5000-01-05, 5000-00-06, 5000-01-07, and 5000-01-08. All serial numbers are affected.
The affected units were distributed domestically across numerous US states and territories, as well as internationally to countries including Canada, the UK, Germany, France, and others. Healthcare facilities should contact Bard Medical Division for instructions on how to return the devices or obtain a replacement.
The recalled product
- Product
- Arctic Sun Temperature Management System, Model 5000. The Arctic Sun¿ 5000 model is a non-invasive, thermal regulating system, indicated for monitoring and controlling patient temperature within a range of 32¿C to 38.5¿C (89.6¿F to 101.3¿F) in adult and pediatric patients of…
- Manufacturer
- Bard Medical Division
- Affected units
- 5,608
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (12)
- Model #5000 Product codes: 5000-00-00
- 5000-00-00L
- 5000-00-00E
- 5000-01-01
- 5000-01-01L
- 5000-01-02
- 5000-01-03
- 5000-01-04
- 5000-01-05
- 5000-00-06
- 5000-01-07
- 5000-01-08. All serial numbers are affected.
Distribution
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